Design Control SOP

In stock
SKU
MD001
$220.00
Samples
Medical Devices Design Control SOP

This Design Control Standard Operating Procedure (SOP) is ready to use and meets the expectations of a structured development by guiding the design efforts through well defined input and output phases. The 11-page SOP only needs some minor manufacture or design center specific modification before it can be used for your development.

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Design Control SOP

Governmental agencies in the world of Medical Devices, in particular the FDA (CDRH), are challenging companies continuously in regard to their Design Control Program. For the recent years it was always one of the top 5 findings in warning letters. The development of a new medical device or main design changes must be managed in a structured environment, which will be the basis of the Design History File (DHF) as well as the Design Master Record (DMR). That is the basis to consistently deliver the intended performance, safety and quality attributes of a medical device. This Design Control Standard Operating Procedure (SOP) is ready to use and meets the expectations of a structured development by guiding the design efforts through well defined input and output phases. The 11-page SOP only needs some minor manufacture or design center specific modification before it can be used for your development.

 

Regulatory basis, reference documents for this Design Control SOP

21 CFR Part 820 - Quality System Regulation, Subpart C - Design Controls, 820.30 Design controls

ISO 13485:2003: Medical Devices - Quality management systems ¬Requirements for regulatory purposes

FDA/CDRH - Design Control Guidance for Medical Device Manufacturers, March 11, 1997

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Design Control SOP - Table of Content

1 Purpose

2 Objective

3 Regulatory basis, reference documents

4 Responsibility and accountability

4.1 COMPANY Management

4.2 Design Review Committee

4.3 Quality Assurance

4.4 Project Leader (PL) / Head of Engineering (HE)

4.5 Function / Area Leaders         

5 Related documents      

6 Definitions       

7 Procedure       

7.1 Design Control (general)         

7.2 Design and Development Planning       

7.3 Phase 2 - Design Inputs          

7.4 Phase 3 - Design Outputs       

7.5 Phase 4 - Design Verification  

7.6 Phase 5 - Design Validation    

7.7 Phase 6 - Design Transfer       

7.8 Design Changes          

7.9 Risk Analysis  

7.10 Design History File      

7.11 Project Start   

7.12 Design and Development Plan 

8 Attachments    

9 SOP distribution

10 Health, safety and environmental considerations


Size and Format:

  • Microsoft Office 2003
  • Word File
  • 11 pages procedure
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